Asphyxia Neonatorum Clinical Trial
— NeoSupraOfficial title:
Neonatal Supraglottic Airway Trial: A Single-centre, Open-label, Randomized Clinical Trial to Evaluate the Efficacy of I-gel® Supraglottic Airway Used in Neonatal Resuscitation in Reducing Early Neonatal Mortality and Morbidity
Verified date | June 2020 |
Source | Centre For International Health |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Mortality rates from birth asphyxia in low-income countries remain very high. Face mask
ventilation (FMV) is the most common method of resuscitating neonates in such settings. It is
mostly performed by midwives but may not always be satisfactory. The i-gel® is a cuffless
supraglottic airway which is easy to insert and provides an efficient seal that prevents air
leakage with the potential to enhance the performance of neonatal resuscitation. Midwives can
be trained in a short time to use this method. A pilot study in Uganda has demonstrated that
midwives can safely perform resuscitation of newborn with the i-gel.
OBJECTIVE To investigate whether the use of a cuffless supraglottic airway compared to
face-mask ventilation during neonatal resuscitation can reduce early neonatal death (before 7
days of life) or morbidity in neonatal encephalopathy (NE) in asphyxiated neonates.
STUDY DESIGN, SETTING AND POPULATION A single-centre randomized clinical trial will be
conducted at Mulago National Referral Hospital, Kampala, Uganda, among asphyxiated neonates
in the delivery units. Prior to the intervention, all staff in the labour ward performing
resuscitation will receive training according to the HBB curriculum with a special module for
training on supraglottic airway insertion. Resuscitation will be performed according to
international guidelines.
UTILITY OF THE STUDY It is crucial to explore alternative, cost-effective modalities that not
only would reduce mortality, but also the burden of neurological damage in survivors.
Status | Active, not recruiting |
Enrollment | 1163 |
Est. completion date | December 2021 |
Est. primary completion date | August 12, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A to 10 Minutes |
Eligibility |
Inclusion Criteria: - Inborn baby (=born in the hospital) - Expected = 34-week gestation - Expected birth weight = 2000 g - Need for PPV at birth - Parental consent Exclusion Criteria: - Major malformations (incompatible with sustained life or affecting the airways) |
Country | Name | City | State |
---|---|---|---|
Uganda | Mulago National Referral Hospital | Kampala |
Lead Sponsor | Collaborator |
---|---|
Centre For International Health | Doctors with Africa - CUAMM, Karolinska Institutet, Makerere University, University of Padova |
Uganda,
Pejovic NJ, Myrnerts Höök S, Byamugisha J, Alfvén T, Lubulwa C, Cavallin F, Nankunda J, Ersdal H, Segafredo G, Blennow M, Trevisanuto D, Tylleskär T. Neonatal resuscitation using a supraglottic airway device for improved mortality and morbidity outcomes in a low-income country: study protocol for a randomized trial. Trials. 2019 Jul 19;20(1):444. doi: 10.1186/s13063-019-3455-8. — View Citation
Pejovic NJ, Trevisanuto D, Lubulwa C, Myrnerts Höök S, Cavallin F, Byamugisha J, Nankunda J, Tylleskär T. Neonatal resuscitation using a laryngeal mask airway: a randomised trial in Uganda. Arch Dis Child. 2018 Mar;103(3):255-260. doi: 10.1136/archdischild-2017-312934. Epub 2017 Sep 14. — View Citation
Pejovic NJ, Trevisanuto D, Nankunda J, Tylleskär T. Pilot manikin study showed that a supraglottic airway device improved simulated neonatal ventilation in a low-resource setting. Acta Paediatr. 2016 Dec;105(12):1440-1443. doi: 10.1111/apa.13565. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Composite outcome of either a) early neonatal death or b) neonatal encephalopathy | A composite outcome of a) early neonatal death (within 7 days) b) neonatal encephalopathy (admission to NICU with a Thompson score of 11 or above in day 1-5 during hospitalisation). | Day 7 of life | |
Secondary | Number of adverse events (AEs) and serious adverse events (SAEs) | Safety of i-gel in the hands of non-doctor birth attendants (AEs and SAEs) | Day 7 of life | |
Secondary | Early neonatal death | Early neonatal death (within 7 days) | Day 7 of life | |
Secondary | Very early neonatal death | Very early neonatal death (within 24 hours) | Day 1 of life | |
Secondary | Neonatal encephalopathy | Neonatal encephalopathy (admission to NICU with a Thompson score of 11 or above in day 1-5 during hospitalisation). | Day 7 of life | |
Secondary | Mild neonatal encephalopathy | Neonatal encephalopathy (admission to NICU with a Thompson score of 7 or above in day 1-5 during hospitalisation). | Day 7 of life | |
Secondary | Any hospital admission | Any hospital admission | Day 7 of life | |
Secondary | Advanced resuscitation | Advanced resuscitation including intervention by supervising physician | Day 7 of life |
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